Acute and Residual Effects of Caffeinated Beer

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo. Under the alcohol conditions, participants will receive sufficient alcoholic beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144 undergraduate and graduate students, and recent college graduates.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston University
• Collaborators: Brown University; Centers for Disease Control and Prevention; University of Michigan
• Treatments: Caffeine; Ethanol; Methamphetamine

Criteria

Inclusion Criteria:

• College students, graduate students, or recent graduates

• Between the ages of 21 and 30 years inclusive (as verified by valid drivers license)

• Who, if a student, reports good academic standing

• Have not been diagnosed with a sleep disorder

• Are not daily smokers

• At least occasionally in the past month, consume five drinks (for men) or more (four or more if female [based on Flannery et al 2002]) during a single drinking episode

• Have a valid drivers license, so as to include only people who know how to drive.

Exclusion Criteria:

• Scores of 5 or more on a screening measure for alcoholism (the short version of the Michigan Alcohol Screening Test [SMAST])

• A history of counseling or treatment for chronic substance abuse by self-report

• Daily smoker (to mitigate confounding of caffeine by nicotine withdrawal, or acute nicotine administration, smokers will be excluded from participation)

• Current use of medications that affect the sleep/wake cycle or daytime alertness or that are contraindicated for alcohol

• Presence of a health condition that contraindicates alcohol

• Diagnosis of a sleep disorder (sleep apnea, narcolepsy, periodic limb movement, restless legs syndrome, circadian rhythm disorder, and insomnia)

• Use of recreational drugs (e.g., marijuana) while participating in the study

• Working overnight shifts

• Female and pregnant, nursing, or not using reliable birth control

• Participants who have traveled across two or more time zones in the last month will be rescheduled for later participation (minimum of 1 month from time-zone travel)

• On average consume greater than 4 cups of coffee per day (>400 mg/day)

• Participants who report ever getting motion sick during screening or become motion sick after practicing on the driving simulator during Session 1.

• Weigh more than 230 Lbs.